Novel Food Information - High Pressure Processing (HPP)-Treated Fruit and Vegetable-Based Juices

Health Canada has notified Gridpath Solutions Inc., that it has no objection to the food use of High Pressure Processing (HPP)-treated fruit and vegetable-based juices. The Department conducted a comprehensive assessment of these HPP-treated food products according to its Guidelines for the Safety Assessment of Novel Foods. These Guidelines are based upon internationally accepted principles for establishing the safety of foods with novel traits.

Background

The following provides a summary of the notification from Gridpath Solutions Inc. and the evaluation by Heath Canada and contains no confidential business information.

1. Introduction

This Novel Food Information document has been prepared to summarize the opinion regarding the subject products provided by the Food Directorate, Health Products and Food Branch, Health Canada. This opinion is based upon the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods.

For the purpose of the assessment, the petitioner provided information on four representative juices containing a variety of ingredients: Green (containing kale, spinach, romaine lettuce, parsley, and mint); Red (containing beet, cabbage, pepper, and various berries); Orange (containing carrot, orange, and grapefruit); and Yellow (containing lemon, pineapple, apple, lime, ginger, and agave syrup). The pH values of these products are below of 4.6.

The original manufacturing process does not have a lethality treatment (e.g., heat), thus the safety of these products relies solely on the sanitation of the raw materials and storage conditions. The petitioner wishes to enhance the safety of their products by using an HPP-treatment (i.e., 87,000 psi/600 MPa for 2 minutes). The application of the HPP treatment bestows the benefit of shelf life extension to these products.

In the event of an interrupted cycle, the HPP treatment must be restarted from the beginning of the treatment cycle. Thus, these products may, as consequence of an interrupted cycle, be subject to more than the intended 2-minute cycle. The petitioner therefore provided data for these HPP-treated juice products treated at 87,000 psi/600 MPa for up to 9 minutes.

The assessment conducted by the Food Directorate considered the intended addition of an HPP treatment to the original manufacturing process, the nutritional composition of both HPP-treated and untreated juice products, the potential for the HPP treatment to generate any toxic compounds within each product, and the microbiological safety of the finished HPP-treated products.

The Food Directorate has a legislated responsibility for pre-market assessment of novel foods and novel food ingredients as detailed in the Food and Drug Regulations (Division 28). Fruit and vegetable-based juices treated by high pressure processing (HPP) are considered novel foods under the following part of the definition of novel foods:

"b) a food that has been manufactured, prepared, preserved or packaged by a process that

1. has not been previously applied to that food, and
2. causes that food to undergo a major change."

2. Development of the novel food

Gridpath Solutions Inc. has provided information describing the methods and parameters used to assess the impact of the HPP treatment on the nutritional composition, microbiological safety, and toxicological safety of the treated products.

Nutritional, microbiological, and toxicological data were provided for the HPP-treated products treated with HPP at 87,000 psi/600 MPa for a minimum of 2 minutes up to a maximum of 9 minutes or untreated (negative control).

Samples were treated with HPP using a batch method. Prior to pressurization, the bottled samples were loaded onto a tray, which itself was loaded into the pressurization chamber. The chamber was then sealed and pressurized by injecting water into the chamber until the defined pressure (i.e., 87,000 psi/600 MPa) was reached. Treatment pressure was maintained for a single 2-minute or 9-minute cycle. Control samples were not subjected to HPP treatment. All samples were bottled in materials acceptable for the intended HPP treatment. The HPP-treated food products still required refrigeration.

3. Dietary Exposure

It is expected that HPP-treated fruit and vegetable-based juices will be consumed at a similar rate compared to their non-treated counterparts.

4. Chemistry

The HPP-treated juices are packaged in polyethylene terephthalate (PET) bottles. The petitioner submitted to the Food Packaging Materials and Incidental Additives Section a migration study for their PET bottles. The bottles were subjected to 87,000 psi/600 MPa for a maximum of 15 minutes. The subject bottles were made of one of the following PET resins: M&G 8006, Starpet 1708, Dak CF746A, and PET resin resulting from recycling process Clean Tech CT2500D. Based on the information provided, the Section does not object to the proposed HPP treatment (i.e., 87,000 psi/600 MPa for up to 15 minutes) of these PET bottles.

The safety of all packaging materials is regulated under Division 23, Part B of the Food and Drug Regulations. It is the ongoing responsibility of the manufacturer to ensure that the packaging materials used for their product are acceptable for their intended use. Should the petitioner wish to use packaging materials not previously evaluated for HPP treatment, it is recommended that they contact the Food Packaging Materials and Incidental Additives Section of the Bureau of Chemical Safety. A list of all packaging materials (including those acceptable for HPP treatment) accepted by the Canadian Food Inspection Agency (CFIA), for use in federally-registered establishments, is available on the  CFIA website.

5. Microbiology

The petitioner states that the quality of the finished HPP-treated products is measured against the following microbiological specifications: a total aerobic plate count of less than 105 CFU/ml, a coliform count of less than 10 MPN/ml, an Escherichia coli count of less than 10 MPN/ml, a yeast count of less than 104 CFU/ml, a mold count of less than 104 CFU/ml, and a Lactobacilli count of less than 104 CFU/ml. The petitioner provided data from 4 samples of each HPP-treated juice product to demonstrate that their specifications are consistently met in a production run.

6. Nutrition

The petitioner submitted compositional and nutritional data on the Orange juice product (both HPP-treated and untreated) to demonstrate that the HPP treatment had little or no effect on the nutritional composition of the juices. A rationale, based on the scientific literature, was also provided to support that a HPP treatment of 87,000 psi/600 MPa up to a maximum of 9 minutes would not alter the nutrient content of the juices.

Nutritional analysis was performed on triplicate samples of the Orange juice product (both HPP-treated and untreated). Beta carotene was selected as a nutritional marker to observe potential effects on nutritional composition. No changes or differences were observed for beta carotene levels analyzed between the HPP-treated and untreated samples.

7. Toxicology

The juice products that are the subject of this petition consist primarily of water (~80 -90%). The remaining constituents are primarily carbohydrates (mostly sugars, ~ 11 - 13%), followed by organic acids, vitamins and minerals. Levels of protein, fat, fibre, and minerals are very low.

The most abundant sugars in fruit (sucrose, fructose, and glucose) are not affected by HPP. Other components, such as citric acid and ascorbic acid, are less affected by HPP than by thermal treatment. The generation of volatiles detected in the headspace is comparable for HPP and heat treatment for equivalent levels of microbiological control.

Health Canada has previously assessed that HPP treatment at 87,000 psi/600 MPa for up to 9 minutes did not oxidize the fat in avocados nor affect the pH in tomato-based salsas. It has previously been shown that HPP treatment does not significantly affect the level of glucosinolates in fruit and vegetable-based smoothies.

A study (Vervoot et al., 2013) comparing the volatile compounds produced by thermal and HPP treatment of carrots found that thermal treatment resulted in significantly more Maillard reactions (mostly furans), unsaturated fatty acid oxidation (mostly aliphatic aldehydes), and carotenoid degradation than did HPP at similar levels of microbial safety. Differences between the two kinds of processing became more pronounced at higher intensities. Despite the different state of the treated products (i.e., solid cut carrots in the study and liquid juices in the present petition) their findings are relevant to the present review as the petitioner is using a mixture of fruits and vegetables to make juices.

Small molecules in fruits and vegetables, such as organic acids, vitamins, colours, and flavour compounds, are covalently bound and are generally unaffected by HPP. The stability of sugars, organic acids, vitamins, and other constituents during HPP suggests that compounds of toxicological concern are unlikely to be generated in juices made from fruits. Formation of such compounds has not been demonstrated to occur during the HPP treatment of meat and fish products, whose protein content is much higher and where the formation of such compounds is considered more likely.

HPP has a history of safe use in several jurisdictions, with over 100 juice products marketed around the world. It has been used since 1990 in Japan, since 1996 in the USA, and since 2001(for fruit preparations) in the European Union. The German Research Foundation (DFG) published its opinion (English version) on the safety of HPP-treated foods (Eisenbrand, 2005). In 2013, Food Standards Australia New Zealand (FSANZ) published its opinion that HPP-treated food products are not novel foods.

The evidence to date supports the safety of HPP for fruit and vegetable-based products under the conditions proposed by the petitioner (i.e., 87,000 psi/600 MPa for a minimum of 2 minutes up to a maximum of 9 minutes).

8. Labelling

Exposure to the HPP treatment of 87,000 psi/600 MPa for up to 9 minutes does not cause a significant compositional change in the treated food, nor have there been any safety concerns raised regarding the use of this process for fruit and vegetable-based juices. On this basis, mandatory labelling requirements are not necessary in this case.

Conclusion

Health Canada's review of the information presented in support of the food use of fruit and vegetable-based juices that have been treated at 87,000 psi/600 MPa for a minimum of 2 minutes up to a maximum of 9 minutes concluded that this use does not raise concerns related to food safety. Health Canada is of the opinion that these HPP-treated food products are as safe as their untreated counterparts on the Canadian market.

This opinion is solely with respect to the suitability of sale of these HPP-treated food products. It is the continuing responsibility of the food manufacturer or importer to ensure that their products are in compliance with all applicable statutory and regulatory requirements. Any new information obtained in relation to these products which have potential health and safety implications should be forwarded to Health Canada for our consideration in order to ensure the continued safety and integrity of all foods available in the Canadian marketplace. The sale of a food which poses a hazard to the health of consumers would contravene the provisions of the Food and Drugs Act.

References

Eisenbrand G. 2005. Safety assessment of high pressure treated foods. Mol. Nutr. Food. Res. 49: 1168 - 1174.

Vervoot, L. T Grauwet, DM Njoroge, I Van der Plancken, A Matser, M Hendrickx, and A Van Loey. 2013. Comparing thermal and high pressure processing intensities by headspace fingerprinting. Inn Food Sci Emerg Tech. 18: 31 - 42.

This Novel Food Information document has been prepared to summarize the opinion regarding the subject product provided by the Food Directorate, Health Products and Food Branch, Health Canada. This opinion is based upon the comprehensive review of information submitted by the petitioner according to the Guidelines for the Safety Assessment of Novel Foods.

(Également disponible en français)

For further information, please contact:

Novel Foods Section
Food Directorate
Health Products and Food Branch
Health Canada, PL2204A1
251 Frederick Banting Driveway
Ottawa, Ontario K1A 0K9
novelfoods-alimentsnouveaux@hc-sc.gc.ca